Oritavancin for Staphylococcus Aureus Infections in Opioid Users

A Pilot Proof of Concept Single-Center Study of the Use of Oritavancin in Systemic Staphylococcus Aureus Infections in Patients With Opioid Use Disorder

This will be a pilot single-arm study consisting of 15 participants evaluating the use of oritavancin in the final consolidation phase (last two weeks of treatment) of systemic infections with Staphylococcus aureus (S. aureus) in opioid users.

The purpose of this pilot proposal is to collect information for a subsequent large, randomized intervention. Primary endpoints will be 1) Safety and tolerability, and 2) Duration of hospitalization and rate of recurrence.

Study Overview

• Status: Withdrawn
• Conditions: Staphylococcus Aureus Bacteremia; Staphylococcus Aureus Endocarditis
• Intervention / Treatment: Drug: Oritavancin Injection

Detailed Description

This will be an early phase, single center, open label pilot study of 15 participants designed to evaluate the effects of oritavancin in patients with Opioid Use Disorder and/or Intravenous Drug Use and systemic S. aureus infections. In this study systemic infections refers to bacteremia or Infectious Endocarditis. Participants who meet inclusion and exclusion criteria will receive a single 1200mg infusion of oritavancin to complete 4 weeks of antibiotic therapy (including the inpatient phase) for isolated bacteremia and 6 weeks for IE. Participants will be evaluated weekly until completion of treatment and then at week 4 and week 6 after the infusion of oritavancin. Participants will have blood drawn at each visit to monitor for toxicity and pharmacokinetics and will be evaluated clinically and by culture for the presence of relapse of the infection. At the last visit, participants will have an echocardiogram.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104--607
      • Clinical Trials Unit. University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age and older
• Systemic infection with S. aureus
• Afebrile for >48 hours
• Negative blood cultures for at least 48 hours
• Absolute neutrophil count (ANC) equal or greater 750/mm3
• Hemoglobin > 9.0 g/dL
• Platelet count equal or > 50,000/mm3
• Creatinine < 2.0 x ULN
• AST ; ALT, and alkaline phosphatase < 2.0 x ULN
• Willing to use a medically accepted method of contraception

Exclusion Criteria:

• Require valve replacement surgery
• Have prosthetic material in body (This includes prosthetic heart valves and/or prosthetic joints)
• Septic emboli to central nervous system or lungs
• Breast feeding during entire participation
• Pregnant
• Polymicrobial infection
• Require anticoagulation
• Allergy to vancomycin or oritavancin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Oritavancin; Single IV infusion of 1200mg of oritavancin	Drug: Oritavancin Injection; single 1200mg infusion of IV oritavancin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of grade 3 or 4 systemic (i.e., not a local reaction) adverse events associated with the administration of oritavancin	Safety	6 weeks
Frequency of relapse of infection	Efficacy	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	Duration of hospitalization	6 weeks
Relapse of systemic S. aureus infections	Relapse of systemic S. aureus infections. Relapse will be defined as an isolation of the same S. aureus strain in subsequent cultures	6 weeks
Pharmacokinetic parameters of oritavancin: Cmin (μg/ml)	Cmin (μg/ml) at week 1, 2, 4 and 6 after the administration of oritavancin	6 weeks
Patient satisfaction when using oritavancin measured using the Patient Satisfaction Questionnaire Short Form (PSQ-18)	Patient satisfaction will be measured using The Patient Satisfaction Questionnaire Short Form (PSQ-18)	6 weeks

Collaborators and Investigators

• Sponsor: University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2019
• Primary Completion (ACTUAL): March 24, 2022
• Study Completion (ACTUAL): March 24, 2022

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: November 30, 2018
• First Posted (ACTUAL): December 3, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Sepsis; Bacteremia; Endocarditis; Staphylococcal Infections; Anti-Infective Agents; Anti-Bacterial Agents; Oritavancin
• Other Study ID Numbers: 831334

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No